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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Table, Operating-Room, Ac-Powered
510(k) Number K950192
Device Name SKYTRON SKYBOOM SERIES
Applicant
Skytron, Div. the Kmw Group, Inc.
5000 36th St. SE
P.O.Box 888615
Grand Rapids,  MI  49588 -8615
Applicant Contact DAVID M MEHNEY
Correspondent
Skytron, Div. the Kmw Group, Inc.
5000 36th St. SE
P.O.Box 888615
Grand Rapids,  MI  49588 -8615
Correspondent Contact DAVID M MEHNEY
Regulation Number878.4960
Classification Product Code
FQO  
Date Received01/18/1995
Decision Date 04/03/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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